Challenges in Implementing Hospice Clinical Trials: Preserving Scientific Integrity While Facing Change
Challenges in Implementing Hospice Clinical Trials: Preserving Scientific Integrity While Facing Change
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DOI：
10.1016/j.jpainsymman.2019.09.028
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发表时间：
2020-02-01
影响因子：
4.7
通讯作者：
White, Patrick
中科院分区：
文献类型：
--
作者：
Oliver, Debra Parker;Washington, Karla T.;White, Patrick
背景/目标。在临床试验的原始设计计划、资金建议的提交和临床试验的实施之间，可能会发生许多变化。在临终关怀环境中，环境变化可能会带来重大障碍，这需要改变最初的计划设计、招聘和人员配置。这项研究的目的是分享经验教训和问题解决策略，以帮助未来的临终关怀试验。这项研究以一项临终关怀临床试验为样本，展示了在这种背景下临床试验研究面临的挑战。使用在试验的头几个月收集的初步数据，研究团队详细说明了他们目前的方案反映与最初提出的计划相比的变化的许多方式。本文以经验作为范例来解决以下问题：1)从最初提交资金提案到最终获奖，研究环境是如何变化的？2)研究人员如何保持研究的完整性并适应研究环境中的意外变化？结果。临终关怀环境的变化要求在第一年内进行设计、抽样和招聘方面的更改。决策过程导致了更强大的设计和更大的普遍性。作为必要的方案更改的结果，研究结果被定位为遵循研究结论的翻译。研究人员最好在临床试验的早期审查他们的方案和统计数据。他们应该做好调整的准备，以适应他们控制之外的市场和环境变化。建议进行持续的数据监测，特别是与征聘有关的数据。(C)2019年美国临终关怀与姑息医学学会。爱思唯尔公司出版，版权所有。
Background/Aims. Numerous changes can occur between the original design plans for clinical trials, the submission of funding proposals, and the implementation of the clinical trial. In the hospice setting, environmental changes can present significant obstacles, which require changes to the original plan designs, recruitment, and staffing. The purpose of the study was to share lessons and problem-solving strategies that can assist in future hospice trials.Methods. This study uses one hospice clinical trial as an exemplar to demonstrate challenges for clinical trial research in this setting. Using preliminary data collected during the first months of a trial, the research team details the many ways their current protocol reflects changes from the originally proposed plans. Experiences are used as an exemplar to address the following questions: 1) How do research environments change between the initial submission of a funding proposal and the eventual award? 2) How can investigators maintain the integrity of the research and accommodate unexpected changes in the research environment?Results. The changing environment within the hospice setting required design, sampling, and recruitment changes within the first year. The decision-making process resulted in a stronger design with greater generalization. As a result of necessary protocol changes, the study results are positioned to be translational following the study conclusion.Conclusion. Researchers would do well to review their protocol and statistics early in a clinical trial. They should be prepared for adjustments to accommodate market and environmental changes outside their control. Ongoing data monitoring, specifically related to recruitment, is advised. (C) 2019 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.